Learn More About FDA Warnings to Doctors About Fake Cancer Drugs

May 2, 2012

The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.

“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.

“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.

“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.

“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

LEARN MORE ABOUT COUNTERFEIT CANCER MEDICATIONSIN THE US AT THE 2012 PARTNERSHIP FOR SAFE MEDICINES INTERCHANGE.

The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012. The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).

Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA’s blog, “For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.”

The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.

“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.

“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.

LEARN MORE ABOUT COUNTERFEIT CANCER MEDICATIONSIN THE US AT THE 2012 PARTNERSHIP FOR SAFE MEDICINES INTERCHANGE.

“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.

“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012. The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).

“FDA is aware of promotions and sales of unapproved injectable cancer medications direct-to-clinics in the U.S, which most likely were administered to patients,” states the memo.

Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA’s blog, “For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.”

One among those that received the recent letters was Dr. Isabella Martire, of Laurel, MD who pleaded guilty to introducing a misbranded drug into interstate commerce in August, 2011. Dr. Martire admitted to using drugs not approved by the FDA to treat cancer patients in order to save almost $800,000 per year. She admitted to purchasing $200,000 of misbranded drugs and then sought reimbursement from public and private health insurance plans for the actual costs.

Tom Kubic, President and CEO of the Pharmaceutical Security Institute warned that doctors are integral stakeholders in a safe and secure supply chain, “If you’re a doctor running a U.S. clinic and you’re willing to dispense medicines with French packaging, what good is an RFID tracker? You’ve got to have some integrity on both ends.”